EP3139222A1

EP3139222A1 - Analytical test management system and method

Info

Publication number: EP3139222A1
Application number: EP15183878.6A
Authority: EP
Inventors: Sascha Antoni; Martin Burri; Werner Doeppen; Bernhard Eckert
Original assignee: F Hoffmann La Roche AG; Roche Diagnostics GmbH
Current assignee: F Hoffmann La Roche AG; Roche Diagnostics GmbH
Priority date: 2015-09-04
Filing date: 2015-09-04
Publication date: 2017-03-08
Anticipated expiration: 2035-09-04
Also published as: JP2017049254A; EP3139222B1; JP6823974B2; US20170067922A1; CN106548039A; CN106548039B; US10101349B2

Abstract

Disclosed is an analytical test management system and method that can in certain embodiments reduce the likelihood that errors are made during the performance of combinations of analytical tests that together are used to provide an analytical result that can be the basis of a diagnosis or a treatment decision. In one embodiment, test orders submitted through a test order interface are received at a test manager module that decides whether the test order is for a simple test or whether the test order is for a combination of tests. If the test order is for a simple test, the test order is forwarded to an analyzer for processing. If the test order is for a combination of tests that together lead to a final result, the test order manager module assumes control over the test order and directs the analyzer according to secondary test requests, the results of which are used by the test order manager module to, for example, decide whether additional secondary test requests should be sent to the analyzer or make calculations used to provide the final result.

Description

BACKGROUND

In certain circumstances, medically important information does not come from a single test, but rather, it is a combination of tests that yields the result needed by a health care professional to make a treatment decision for a patient. As the complexity of these combinations of tests increases, the likelihood that a mistake is made increases, particularly when the tests are ordered individually and results of differing quality are combined to provide the result on which treatment is based.
A related challenge facing providers of medical testing systems is that along with increased need to extract additional medical value from existing and new combinations of tests come increased regulatory and quality requirements. The regulatory demand placed on these providers is particularly heightened when the outcome of a complex set of tests is the basis of an impactful diagnosis, or a decision regarding the choice of drug to most effectively combat a potentially fatal disease.
Current medical testing systems, particularly when housed in a certified laboratory and staffed by highly qualified personnel, can often meet the regulatory and associated quality control demands that accompany high medical value testing. However, the same is not always true in hospital laboratories, particularly small hospital laboratories, where staffing shortages and lack of training can make it necessary for samples to be transferred to a certified laboratory. Transfer of samples can unnecessarily delay time-critical treatment decisions and often reduces the time during which valid test results can be obtained because samples can degrade over time. And, even in certified laboratories, there are pressures to increase throughput, lower personnel costs, and reduce waste and mistakes, as well as to provide a widening array of test offerings to their customers.
As such, what is needed is a system and method for managing the testing of biological samples that can help meet the demands of patients and health-care providers, now and in the future.

SUMMARY

Disclosed are a system and method for managing analytical tests, particularly, for managing complex combinations of analytical tests, in a reliable and controllable manner.
In one embodiment, an analytical test management system is disclosed. In this embodiment, the system includes an analyzer configured to perform an analytical test on a biological sample, where the test is conducted according to a first set of instructions that are stored in an analyzer memory. For example, the analyzer can follow the first set of instructions to perform physical and/or chemical interrogations and manipulations that lead to a test result. The system of this embodiment further includes a test manager module that is communicatively connected to the analyzer and that uses a second set of instructions stored in a test manager module memory to direct the activity of the analyzer. A test order interface communicatively connected to the test manager module is further included, and is configured to receive a test order for one of an analytical test of a first type (for example, a simple, single analyte test) and an analytical test of a second type (for example, a workflow of several possible tests). The interface transmits the test order to the test manager module, and if the test order is for the analytical test of the first type, the test manager module is configured to forward the test order directly to the analyzer and the biological sample is analyzed by the analyzer according to the first set of instructions. If, however, the test order is for the analytical test of the second type, for example, a combination of tests, the test manager module is configured to handle the test request according to the second set of instructions, and to generate and transmit one or more secondary test requests to the analyzer for execution, at one or more various times.
In a more particular embodiment of the disclosed system, the analyzer memory includes a first set of instructions of a first type and a first set of instructions of a second type. The first set of instructions of the first type is used by the analyzer to process the test order for the analytical test of the first type and the first set of instructions of the second type is used by the analyzer to process the test order for the analytical test of the second type according to the one or more secondary test requests. For example, the first set of instructions of the first type can be a set of instructions that is used to carry out a simple test that directly provides an analysis result, whereas the first set of instructions of the second type can be a set of instructions that provides an intermediate result that is perhaps further used by the test manager module to generate additional secondary tests requests according to the second set of instructions.
In another embodiment, a method for managing analytical tests is disclosed. The disclosed method includes storing a first set of instructions in a memory of an analyzer configured to perform an analytical test on a biological sample and storing a second set of instructions in a memory of a test manager module. A test order of one of two types is received at the test manager module through a first test order interface, and the test manager determines the test order type. If the test order is determined to be for the analytical test of the first type, the test order is sent directly to the analyzer to analyze the biological sample according to the first set of instructions. If the test order is determined to be for the analytical test of the second type, the test manager module generates, according to the second set of instructions, one or more secondary test requests, and these one or more secondary test requests are transmitted to the analyzer.
In a more particular embodiment of the disclosed method, the method further includes storing in the analyzer memory a first set of instructions of a first type and a first set of instructions of a second type, and analyzing the biological sample according to the first set of instruction of the first type if the test order is for the analytical test is of the first type, and analyzing the biological sample according to the first set of instructions of the second type in response to the one or more secondary test requests if the test order is for the analytical test is of the second type.

LIST OF FIGURES

FIG. 1 illustrates an embodiment of the disclosed analytical test management system.
FIG. 2 shows a more particular embodiment of the disclosed analytical test management system.
FIG. 3 shows an embodiment of the disclosed method for analytical test management.
FIG. 4 shows embodiments of linked test applications/reagents and logically linked test applications/reagents
FIG. 5 shows embodiments of how repeat pipetting can controlled within linked tests
FIG. 6 shows an embodiment of an analytical test of a second type
FIG. 7 shows another embodiment of an analytical test of a second type
FIG. 8 shows still another embodiment of an analytical test of a second type
FIG. 9 shows an embodiment for calculated QC in the case of multiple measuring units

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

As used herein, "a" and "the" refer to both the singular and plural referents unless clearly indicated otherwise. The following examples are provided solely to assist the reader in understanding the invention as defined in the claims that follow.
In one aspect, an analytical test management system is disclosed that includes an analyzer, a test manager module, and a first test order interface. The analyzer is configured to perform an analytical test on a biological sample according to a first set of instructions, and the instructions for performing the analytical test are stored in an analyzer memory. The test manager module is communicatively connected to the analyzer and is configured to direct activity of the analyzer according to a second set of instructions, which instructions are stored in a test manager module memory. The first test order interface, which is communicatively connected to the test manager module, is configured to receive a test order for one of an analytical test of a first type and an analytical test of a second type, and to transmit the test order to the test manager module. The test manager module is configured to forward the test order directly to the analyzer if the test order is for the analytical test of the first type, and the biological sample is analyzed by the analyzer according to the first set of instructions. If, however, the test order is for the analytical test of the second type, the test manager module is configured to handle the test order according the second set of instructions and to generate and transmit one or more secondary test requests to the analyzer.
The biological sample to be analyzed can be received by an analyzer in native form or received in a pretreated form, for example, after being transported from a separate pre-analytical system or device. Alternatively, or in addition, the analyzer itself can also perform one or more pre-treatment procedures prior to analysis of the biological sample. Particular examples of pre-treatment procedures include preparation of aliquots, separation of sample components, concentration or dilution of the sample or components thereof, and removal of interfering substances or materials. Examples of biological samples include blood, saliva, ocular lens fluid, cerebrospinal fluid, sweat, urine, stool, semen, milk, ascites fluid, mucous, synovial fluid, pus, peritoneal fluid, amniotic fluid, tissue, and cultured cells, or any sample obtained or otherwise derived from the same, for example, serum obtained from blood.
As shown in the embodiment of FIG. 1, a first test order interface (10) is communicatively connected to the test order manager module (20). The first test order interface (10) that is communicatively connected to the test manager module can be, for example, a laboratory system control device, such as a PC system that is used by laboratory personnel to enter test orders for execution on one of several analyzers and to receive test results through the test order manager module (20). Alternatively, the first test order interface (10) can receive test orders that are entered into a laboratory middleware system, that are communicated through a laboratory middleware system from a host system (e.g. an HIS or LIS system), or that are communicated directly from a host system. Likewise, test results can be delivered back to the middleware system (for example, for QC checks) and to the host system (for example, for viewing by a healthcare professional). For example, the first test order interface can receive test orders from any one of several host system user interfaces that are communicatively connected to the host system, such as host system interfaces that are distributed within a health care facility, and deliver test results back to those host system user interfaces. It is possible and typical to have one or more user interfaces for entry of test order through each of the laboratory system control device, the middleware system, and the host system.
As further shown in the embodiment of FIG. 1, the test order manager module (20) is communicatively connected to an analyzer (30) and can be further communicatively connected to one or more additional analyzers (30a, 30b). The analyzer (30) and additional analyzer(s) (30a, 30b) can be of any type of known or yet to be developed system that interrogates a biological sample using physical, chemical and/or biological means to provide a test result for a particular analyte or group of analytes. The test result can be, for example, raw data or counts, a calculated result, or a combination thereof. The analyzer can utilize any of a variety of techniques and methods to provide a measure of an analyte's presence, and/or concentration, and/or interaction with other molecules or cells within the biological sample. Particular examples of analyzers include immunochemical analyzers, mass spectrometric analyzers, cytometric analyzers, chemical analyzers, fluorescence analyzers, electrochemical analyzers, electro-physical analyzers, optical analyzers, microscopic analyzers, nucleic acid sequence analyzers, PCR (or other NA amplification) analyzers, and combinations thereof.
The analyzer (30) and the one or more additional analyzers (30a, 30b) of can include both software and hardware components that are used together to receive a sample, receive a test order or test request associated with the sample, analyze or otherwise process the sample according to the test order or test request, and provide a test result as output. The analyzer (30) and the one or more additional analyzers (30a, 30b) can include an analyzer controller (38, 38a, 38b; which also can be referred to as an analyzer CPU or an analyzer processor) configured to direct the handling of test orders, secondary test requests and test results, and direct the performance of manipulations and measurements made on a sample. The logic used by the controller to operate an analyzer (30) and the one or more additional analyzers (30a, 30b) can be embodied in software, firmware, or a combination of both. The hardware components that are part of an analyzer (30) and the one or more additional analyzers (30a, 30b) can include, for example, pipettors; barcode readers; RFID readers; NFC readers; grippers, tube handlers, rack handlers, reagent pack handlers and other structures to move samples and consumables around inside an analyzer; waste handlers; mixers; shakers; stirrers; incubators; heaters; coolers; blood smear generators; sample printing/deposition devices; slide handlers; microscopes; ECL detectors; electrodes; mass detectors; spectrometers; photometers; and the like; and any combination of these and other known or later developed analyzer hardware components.
Also as shown in the embodiment of FIG. 1, the test manager module can include a test manager module memory (22) having stored thereon a second set of instructions (24) for handling an analytical test of the second type. When a test order is received from the first test order interface (10), the test manager module controller (28) is configured to handle the incoming test order by determining whether the test order is a test order for an analytical test of the first type or is a test order for an analytical test of the second type. If the test order is for an analytical test of the first type, the test manager module controller (28) forwards the test order directly to the analyzer (30) or to one of the additional analyzers (30a, 30b), if they are present, according, for example, to a load balancing algorithm also stored in the test manager module memory (22) or according to instructions received from a laboratory middleware system. If the test order is for an analytical test of the second type, the test manager module controller (28) generates one or more secondary test requests according to the second set of instructions (24), and the one or more secondary test requests are sent by the test manager module controller (28) to the analyzer (30) or to one of the additional analyzers (30a, 30b), if they are present, according, for example, to a load balancing algorithm also stored in the test manager module memory (22), or according to instructions received from a laboratory middleware system. A test result for an analytical test of the first type can be transmitted from the analyzer (30) or one of the additional analyzers (30a, 30b), received by the test manager module (20), and passed directly on to the first test order interface (10) for retrieval by a laboratory system control device, a middleware system, and/or a host system. A test result for an analytical test of the second type, in contrast, can be handled further upon receipt in the test manager module (20) according to the second set of instructions and perhaps also in dependence on the test result value.
In certain embodiments, the second set of instructions can also include predefined calculations based on received test results and predefined calculations of quality control measurements received from an analyzer. Calculations can be based on any combination of any number of previously measured test results transmitted from an analyzer to the test manager module and/or qualitative, semi-quantitative and/or quantitative results previously generated in the test manager module according to the second set of instructions.
The second set of instructions can, in other embodiments, define, for example, the order that different analytical tests will be processed in parallel or sequentially on an analyzer, and in still others, define the order in which reagents will be pipetted for tests processed in parallel or sequentially on the analyzer. The second set of instructions can, in some embodiments, include a series of secondary test requests having different dilution factors for automatic repeats to create a valid test result within a predefined measuring range. Alternatively, the second set of instructions can ensure that test that should be done together, and in a particular order, are performed close in time, with the same reagents, and on the same analyzer. In some embodiments, qualitative results can be generated according to the second set of instructions and used to control further processing of a sample. In still other embodiments, the second set of instructions can include one or more decision steps, for example, a comparison of a test result received from an analyzer with a single value to generate a TRUE/FALSE condition. Alternatively, or in addition, the second set of instructions can include one or more decision steps where different values define the next sequence steps, for example, as reflected in additional secondary test request(s), which in turn can lead to additional decisions and/or additional secondary test request(s) and additional calculations before a final analytical test result is provided to a user of the disclosed system. In these ways, and others, complex testing schemes that are not within the capabilities of certain users can be established on a system.
In particular embodiments, the one or more secondary test requests generated by the test manager module and transmitted to the analyzer include at least two secondary test requests, wherein the results from the at least two secondary test requests are used by the test manager module to determine an analytical result for the analytical test of the second type. In other particular embodiments, the one or more secondary test requests generated by the test manager module and transmitted to the analyzer comprise at least a first secondary test request that is used by the analyzer to generate a first secondary test result that is transmitted back to the test manager module, and in more particular embodiments the test manager module is configured according to the second set of instructions to determine based on the first secondary test result whether one or more additional secondary test requests are required, and if the one or more additional secondary test requests are required, to generate and transmit the one or more additional secondary test requests to the analyzer. In still more particular embodiments, combinations of multiple secondary requests are generated by the test manager module based on multiple results received back from the analyzer in order to automate workflows that might lead to a higher probability of mistakes if done manually by laboratory personnel, and in particular also to ensure that associated QC results are obtained as needed to ensure that they remain valid for each step of a series of interdependent secondary tests requests and thus that any QC calculations based on those QC results are also valid. Likewise, in order to ensure valid results, the test manager module can respond to test failures at any point in a combination of interdependent secondary test requests in a predetermined manner that ensures reliable results. A further benefit of controlling a test order for an analytical test of the second type through the test manager module is that where a result of a first or some subsequent secondary test request indicates that no further testing is required, reagents are saved automatically as the result of the analytical test of the second type is then provided by the test manager module without unnecessary tests being performed.
In other embodiments, the second set of instructions is under the control of the vendor of the tests and cannot be altered by an end user. In these embodiments, there is also the possibility for a vendor to provide testing combinations that meet regulatory requirements for tests used to provide impactful diagnoses (for example, a diagnosis of HIV positive) or determine a course of treatment (for example, Herceptin treatment for an individual with Her2 positive cancer cells present). Vendor reputation can also be safeguarded through vendor control of complex testing procedures.
FIG. 1 also illustrates the more particular embodiment where the analyzer memory (32, 32a, 32b) further include a first set of instructions of a first type (34, 34a, 34b) and a first set of instructions of a second type (36, 36a, 36b), wherein the first set of instructions of the first type is used by the analyzer to process the test order for the analytical test of the first type, whereas the first set of instructions of the second type is used by the analyzer to process the test order for the analytical test of the second type according to the one or more secondary test requests that are supplied to the analyzer (30, 30a, 30b) by the test manager module (20). For example, the first set of instructions of the first type can be used by the analyzer to process an order for a single analytical result, and the first set instructions of the second type can be used by the analyzer to perform a test that is being controlled by the test manager module according to the second set of instructions (24), which might include a combination of multiple test results provided in response to secondary test requests.
In even more particular embodiments, the first instructions of the first type and the first instructions of the second type can lead to the same set of analytical steps being performed by the analyzer, but in the case of the first instructions of the second type, those instructions are linked to one or more additional first instructions of the second type, for example, through the second set of instructions according to which the test manager module directs the analyzer. In other embodiments, the presence of first instructions of the second type (36, 36a, 36b) in an analyzer memory (32, 32a, 32b) causes an analyzer processor (38, 38a, 38b) to reserve or otherwise link reagents present on the analyzer in order that all reagents necessary to fulfill a test order for an analytical test of the second type performed according to the second set of instructions stored in the test manager module (20). In other more particular embodiments, the linking of reagents is performed at the time when the reagents are loaded into an analyzer.
In still other embodiments, the presence of first instructions of the second type in an analyzer memory causes the analyzer to communicate with the test manager module to determine which reagents will be needed to perform an analytical test of the second type, and then the analyzer processor will link the reagents in the analyzer. In more particular additional embodiments, the test manager module can instruct the analyzer processor to link reagents in the analyzer only if there are test orders for the analytical test of the second type in a queue of test orders (such as present in the test manager module, a middleware system or host system) that are to be processed by the test manager module. So, for example, there may be certain times of the day in a hospital when orders for analytical tests of the second type arrive in the laboratory, and thus outside of those times it may be desirable not to link reagents, since in further more specific embodiments, when reagents are linked in an analyzer they can only be used together and when one is depleted or otherwise rendered unusable (for example, through expiration or detected degradation) all linked reagents are disabled and should be removed. Thus, when it is not necessary to link reagents due to having a test order queue that perhaps contains enough test orders for analytical test orders of the first type to exhaust the reagents present on an analyzer, waste of reagents that might occur upon linking can be avoided.
In other embodiments, reagents that are linked, such as a first reagent and a second reagent, are utilized according to the second set of instructions stored in the test manager module in a predetermined order. For example, if an analytical test result obtained using either one of the first reagent and the second reagent is in error, a repeat analytical test can be automatically ordered by the test manager module and the first reagent and the second reagent can be again utilized according to the second set of instructions in the same predetermined order to generate a repeat analytical test result. Since it is possible for both test orders for an analytical test of the first type and an analytical test of the second type to be in a queue of test orders, and that both types of test are being performed in parallel, in certain embodiments, a quality control result obtained by the analyzer according to the first set of instructions of the first type is transmitted to and used by the test manager module also as a quality control result for an analytical result according to the first set of instructions of the second type. Once transmitted to the test manager module, the test manager module can use the "copied" quality control result for QC calculations directly, or in a QC calculation that involves combining multiple QC results according to a particular formula. This might be the case where a particular analytical test is used both to obtain a single result and a result of one of at least two secondary test requests generated in the test manager module and transmitted to the analyzer for execution. An advantage here is that separate QC runs are not needed for both types of analytical tests and QC reagents are thus conserved whenever possible.
In still further embodiments, a biological sample is kept on an analyzer and tested (and possibly retested) until the analytical test of the second type is completed according to the second set of instructions stored in the test manager module. Keeping the sample on the analyzer can help ensure that the proper QC can be done on the sample, and that consistent results are obtained, since in such embodiments, the same reagents will be utilized, and those reagents could, for example, be reagents that are provided in matched sets by a vendor.
FIG. 2 shows a more particular embodiment of the disclosed system. In this embodiment, the test manager module (20) is shown as a component of a laboratory system control device (100), which can be in control of one or more analyzers through their associated analyzer control device (200), and possibly in control of additional components of a laboratory system, for example one or more pre-analytic devices (such as an aliquoter or a centrifuge) and/or one or more post-analytical devices (such as a refrigerated sample storage and retrieval system). The laboratory system control device (100) can include, for example, a laboratory system user interface (120), a laboratory system keyboard (122) and a laboratory system mouse (124) that are communicatively connected to the test manager module (20) and can be used to input a test order into the system. As such the laboratory system control device can act as the first test order interface (10) of the disclosed system.
Also as shown in FIG. 2, the analyzer control device (200) can also include an analyzer user interface (220), analyzer keyboard (222) and analyzer mouse (224) that can be used to control the analyzer directly, and not through a test manager module, and these human/machine interfaces can be used, for example, to input a test order for execution on an analyzer. In more particular embodiments, the analyzer control device (200) is configured only to accept a test order for an analytical test of the first type and not a test order for an analytical test of the second type, and features used to input test orders for an analytical test of the second type are either hidden, not present, or otherwise masked (such as by non-functional display components, perhaps displayed in blurred or in different colors from other display components) in the analyzer user interface (220).
In more particular embodiments, one or the other of, or both of, the laboratory system user interface (120) and the analyzer user interface (220) can be touch-screen interfaces and the mouse and keyboard (or other human/machine interfaces, known or yet to be developed) may or may not be present.
Also shown in the embodiment of the disclosed system in FIG. 2, is a host system (40) which can also include means to input test orders that are then transmitted to the test manager module (20) for processing. As mentioned above, the host system can also include one or more host system human/machine interfaces (not shown) which can be used to input a test order. In particular embodiments, a test order for an analytical test of the second type can only be entered through the host system (40). In other particular embodiments, a test order for an analytical test of the second type can only be entered through the host system (40) or through the laboratory system control device (100), but cannot be entered through analyzer control device (200). In certain embodiments, any of the host system (40; and its associated human/machine interfaces), the laboratory system control device (100), and the analyzer control device (200) can be used to input a test order for an analytical test of the first type.
In even more particular embodiments, the analyzer control device (200) is configured to only accept test orders for an analytical test of the first type from one class of users (such as healthcare providers), but can be used to accept test orders for an analytical test of the second type from a second class of users holding particular administrative rights (e.g. a service technician, or laboratory manager).
As further illustrated by the embodiment of FIG. 2, the test manager module can include some, all of, or at least the components shown therein. For example, a test manager module can include a test manager module hard drive (102) having stored thereon one or more second sets of instructions (104, 106) that are used by the test manager module (20) to process a test request for an analytical test of the second type. Additional components of the test manager module (20) can include a ROM (108), a CPU (110), one or more input/output interfaces (112, 116) used to mediate communication between the test manger module (20) and a human/machine interface, such as keyboard (122). Also shown is a RAM (114) which can be used to temporarily store one or more second sets of instructions (104, 106) as they are executed by CPU (110). Test manager module communications interface (118) functions to mediate the transmission of test orders, secondary test requests and test results between the various components and devices, including the host system (40), the laboratory system control device (100) and the analyzer control device (200). In addition, in certain embodiments, the test manager module communications interface (118) is communicatively connected through an internet (50) to a remote computer (60), which can be a vendor-controlled computer system.
As shown in the embodiment of FIG. 2, an analyzer control unit (201) can include an analyzer control unit hard drive (202) having stored thereon one or more first sets of instructions of a first type (204) and one or more first sets of instructions of a second type (206) that are used by the analyzer control unit (201) to process, respectively, a test request for an analytical test of the first type and a test request for an analytical test of the second type according to one or more secondary test requests transmitted to the analyzer control unit (201) by the test manager module (20) according to the second set of instructions (104, 106). Additional components of the analyzer control unit (201) can include a ROM (208), a CPU (210), one or more input/output interfaces (212, 116) used to mediate communication between the analyzer control unit (201) and a human/machine interface, such as keyboard (222). Also shown is a RAM (214) which can be used to temporarily store one or more of the first instructions of the first type (204) and one or more of the first instructions of the second type (206) as they are executed by CPU (210). Analyzer communications interface (218) functions to mediate the transmission of test orders, secondary test requests and test results between the test manager module (20) and analyzer control unit (201).
A sequence of processing different assays in multiple steps depending on measured results of previous assays is often described by a vendor of the assays. All the steps have to be done manually or they have to be configured on an analyzer by the customer. In this situation, the final processing sequence of multiple assays is not in the control of the vendor of the assays and can be changed or misused by customer. Depending on the analyzer, not all sequences can be done in a fully automated manner and manual steps may be required to initiate further processing.
Thus, according to one embodiment of the disclosed system and method, a vendor of assays can fully control the sequences of these assays (incl. calculations) and can take responsibility for the final result. Since all steps of such a processing sequence can be done in a fully automated manner without any interaction of a user, there can be a reduction in the possible sources of errors and the processing time can be optimized to a minimum duration.
In particular embodiments, one or more second sets of instructions (104, 106) and/or one or more first sets of instructions of a first type (204) and/or one or more first sets of instructions (206) are transmitted from remote computer (60), which can be a computer under the control of a vendor, for storage in test module hard drive (102) and/or analyzer hard drive (202). Alternatively, first and second sets of instructions can be stored in test module hard drive (102) and/or analyzer hard drive (202) by a vendor-employed service technician after transfer from any known or yet to be developed portable storage medium (for example, a CD or a USB stick). In either case, vendor control of the loading of instructions stored in the test module hard drive (102) and/or analyzer hard drive (202) can decrease the possibility that they will be altered by a user and can help the vendor establish that test available to the user are safe and effective. For example, the vendor can provide a closed system including a test order manager module and prevent user access thereto, such as by keeping some or all of the second set of instructions used by the test manager module hidden from and unalterable by a user.
In other particular embodiments, the disclosed system includes a graphical user interface, which can be any or all of a host system GUI, a laboratory system GUI, an analyzer system GUI or other communicatively connected GUI, wherein the graphical user interface is configured to display to a user a final result that is determined based on one or more secondary test results received from the analyzer following execution of the one or more secondary test requests by the analyzer, but not display the one or more secondary test results that were used to determine the final result. An advantage of hiding the underlying secondary test results is that in some instances, the underlying test results could be misleading, and in other instances, such underlying information is simply not needed to make a health care decision. The graphical user interface can be further configured to display underlying test details if desired (such as through a drill-down operation), and in particular embodiments, such underlying test details can be made visible only to certain users having the appropriate access rights, for example, to a service technician for trouble-shooting purposes. In other particular embodiments, the results of underlying secondary test results are not visible on the graphical user interface, but are provided to a user when a test result report is printed.
Although suggestive of hardwire connections in FIGS. 1 and 2, any or all of the illustrated connections between components can be hardwired or wireless (for example, RF or IR). Communication between system components can be mediated using any known or yet to be developed communications protocol and data transfer can be according to any know standard (such as ASTM or HL7).
In another aspect, a method for managing analytical tests is provided, which method includes storing a first set of instructions in a memory of an analyzer configured to perform an analytical test on a biological sample, storing a second set of instructions in a memory of a test manager module, and receiving a test order for one of an analytical test of a first type and an analytical test of a second type in the test manager module through a first test order interface. The method of this aspect further includes determining in the test manager module if the test order is for the analytical test of the first type or the analytical test of the second type, and if the test request is determined to be for the analytical test of the first type, forwarding the test order directly to the analyzer to analyze the biological sample according to the first set of instructions, and if the test order is determined to be for the analytical test of the second type, generating in the test manager module, according to the second set of instructions, one or more secondary test requests, and transmitting the one or more secondary test requests to the analyzer.
In a more particular embodiment, the method further includes storing in the analyzer memory a first set of instructions of a first type and a first set of instructions of a second type, and analyzing the biological sample according to the first set of instruction of the first type if the test order is for the analytical test is of the first type, and analyzing the biological sample according to the first set of instructions of the second type in response to the one or more secondary test requests if the test order is for the analytical test is of the second type. For example, the first set of instructions of the first type can be used by the analyzer to process an order for a single analytical result, and the first set instructions of the second type can be used by the analyzer to perform a test that is being controlled by the test manager module according to the second set of instructions.
One embodiment of the logic of the disclosed method is shown in FIG. 3. At (300), a test order is received at the test order management module from the first test order interface. Upon receipt, a determination as to whether the test order is for an analytical test of the first type or the test order is for an analytical test of the second type. If the test order is for an analytical test of the first type, the test order is directly sent to an analyzer for processing (310), and if the test order is for an analytical test of the second type, the test order is then processed by the test order manager module according to the second set of instructions (320).
Following the right hand side of FIG. 3, a test order for an analytical test order of the first type, once sent to an analyzer (310), is the processed by the analyzer according to first instructions of the first type (312) to provide a test result for the analytical test of the first type, which test result is sent to the test order manager module (314). The test order manager module then provides the test result for the analytical test of the first type available to a user through the first test order interface (316).
Also as shown in left hand side of FIG. 3, the test order manager module processes the test order for an analytical test of the second type (320) and generates one or more secondary test requests (322). The one or more secondary test requests are then sent to an analyzer for processing (324). The analyzer to which the test order manager module sends the one or more secondary test requests can be the same or different from the analyzer to which a test order for an analytical test of the first type is sent. For example, in some embodiments, one analyzer is configured to process only test orders for analytical tests of the first type and another analyzer is configured to process test orders for both an analytical test of the first type and for an analytical test of the second type. In such an embodiment, linking of reagents for use in processing of analytical tests of the second type is performed only in one analyzer and any waste of reagents that occurs because linked reagents are made unusable together can be avoided.
As shown also on the left hand side of the embodiment of FIG. 3, the one or more secondary test requests generated at (322) are sent to the analyzer (324) and are processed by the analyzer according to first instructions of the second type (326). A test result (or results) of processing the one or more secondary test requests is sent from the analyzer to the test order manager module (328), once received at the test order manager module, the test result (or results) of processing the one or more secondary test results are further processed by the test order manager module according to the second set of instructions, and if the processing according to the second set of instructions is complete (329) is complete a test result is provided to a user through the first test order interface (330) and the test order for the analytical test of the second type is fulfilled. For example, a first one or more secondary test requests might provide a test result that according to the second set of instructions indicates no further testing is necessary as the answer is already provided. An advantage to having such a gating test is that further tests according to further secondary test requests are not needed, and resources are conserved automatically.
On the other hand, as shown in the left side of the embodiment of FIG 3, if the first one or more secondary test requests yield a test result or results that when further analyzed by the test order manager module are determined by the test order manger module according to the second set of instructions to require further testing, the test order manager module generates a second one or more secondary test requests (322) and the process is repeated, one or more additional times, such as with third, fourth, fifth or even more additional secondary test requests being generated by the test order manager module until a determination is made at (329) that the test order according to the second set of instructions is complete and a final test result is provided at (330). An advantage of having such an automated sequence is that complex decision trees can be taken out of the hands of inexperienced health care providers and used to produce reliable results. Furthermore, since in more particular embodiments, a biological sample is kept on an analyzer until a final result is provided, regardless of how many secondary test requests are needed to provide a reliable final result, time is not wasted storing a sample and retrieving it multiple times and expiration of the time during which valid test results can be obtained from the sample can be avoided, and thus, the need to take additional samples from a patient can be avoided. Avoidance of sample waste can be especially important when the sample is scarce, such as a blood sample from a tiny, premature infant.
In even more particular embodiments, the first instructions of the first type and the first instructions of the second type can lead to the same set of analytical steps being performed by the analyzer, but in the case of the first instructions of the second type, those instructions are linked to one or more additional first instructions of the second type through the second set of instructions used by the test manager module directs the analyzer in performing analytical tests of the second type. Linking of additional tests through the second set of instructions can be controlled either by the analyzer querying the test manager to determine which tests are linked, or through the presence in the analyzer memory of first instructions of the second type.
In still more particular embodiments, the linking of tests through the second set of instructions also leads to linking of reagents used by the analyzer so that the resources necessary to carry out a particular analytical test of the second type are reserved for use in that particular test. For example, the analytical test of the second type can be a complex combination of individual tests that together can be used to calculate a final test result and perhaps an associated quality control measure, and it is desirable to ensure that all reagents needed to perform the test are available.
All of the above aspects and others are further illustrated in the following non-limiting examples.

Example 1: Linking of Reagents for Analytical Tests of the Second Type under Control of the Test Manager Module

The pipetting sequence of some assays can influence the reliability of certain tests. For those assays it can be that no other pipetting of additional reagents can be done in between the use of two or more particular reagents, and it is desirable that pipetting steps should be as close to each other in time to produce best analytical performance. As shown in FIG. 4A and FIG. 4B, reagents can be linked within one reagent pack (which itself could include one or more reagents) or between two or more reagent packs (which can also include one or more reagents each).
Once linked, pipetting sequences can be defined on an analyzer, and individual applications of linked tests can then be pipetted in a first predetermined sequence for a particular biological sample. In certain embodiments, in case of a measurement failure of at least one of the linked tests, all individual tests must be repeated again in a second predetermined order, which can be the same or different from the first predetermined order.
In the embodiment of FIG. 4A, two first sets of instructions of the second type (400,402), are linked through their used in an analytical test of the second type, and used in response to one or more secondary test requests generated in the test manager module. The linkage in this case between the two first sets of instructions of the second type (400,402) and the reagent pack (404) is a logical link (also referred to linked tests) because both first sets of instructions of the second type utilize the same reagent pack (404) during execution of the secondary test requests. In some embodiments, the link between multiple applications of the same reagent pack (404) are established through an application parameter that is associated with linked first sets of instructions of the second type, and according to this parameter as recognized by the analyzer CPU, linkage of the reagent between tests can be established during loading of the reagent pack (so as, for example, to ensure that enough reagent for all applications that use the reagent will be maintained). In some embodiments, a logical link is implemented in a one way direction where as one of the application is the master application and all additional linked applications then refer to the master application. Thus, there can be a Master/Slave relationship between two or more first sets of instructions of the second type, and one of them (such as 400) can be used also to process a test request for an analytical test of the first type. Also, in some instances, a QC determination for one set of instructions (400) can be copied and used for the other set of instructions (402).
Alternatively, as show in the embodiment of FIG 4B, two or more reagent packs that are used together in response to two or more secondary test requests can be provided in one kit with one kit lot number. In this instance, there can be no Master/Slave relationship between the sets of first instructions of the second type (410,412) since in some particular embodiments, the sets of first instructions of the second type are always executed together for each test order (or possibly repeat). Not only are the sets of first instructions of the second type (410, 412) linked, but also the reagent packs (414, 416) as shown. Such a linkage between sets of first instructions of the second type and two or more different reagent packs can be referred to as linked kits.
Also in the embodiment of FIG. 4B, the first sets of instructions of the second type linked as a kit can also be linked through an application parameter present in the instructions, which can be used by the analyzer CPU to link the reagent packs (414, 416), and the linkage of the reagent packs can be done on system during loading. And, again, it is possible, once the reagent packs are linked, to pipette from the linked reagent packs in a first predetermined sequence for a biological sample, and in case of a measurement failure and repeat, the reagents can be again pipetted in a second predetermined sequence that can be the same as or different from the first predetermined sequence.
It is possible, in some embodiments to have both linked tests (using the same reagent pack) and linked kits (of two or more reagent packs) employed in executing a test order for an analytical test of the second type according to one or more secondary test requests generated in the test order manager module.
Linkage of reagent during loading has the advantage compared to a possible linkage during production of the reagent packs. If the reagent packs would be linked during production, the whole production process and also the user when unpacking would have to take care to ensure that the linked reagent packs are loaded together as a package to the analyzer. With linkage during the loading process, the analyzer can combine any reagent packs from the same lot into a combination of multiple reagent packs. In certain embodiments, reagent packs, once linked, cannot be loaded or unloaded from an analyzer separately.
Furthermore, in some embodiments, based on linkage information, the analyzer can schedule and processes the pipetting sequences as required. In these embodiments, secondary test requests sent form the test order manager module based on the second set of instructions do not have to include information specific instructions regarding pipetting sequences, thereby potentially simplifying development of new tests by a vendor.

Example 2: Restricted Pipetting Order for Linked Reagents

Linkage (logical or as kits) according to the embodiments of FIG. 4A and FIG. 4B above can allow definition of predetermined pipetting orders for reagents. In this example, two specific types of defined pipetting sequences are presented for linkage as kits, which pipetting sequences differ in the way that repeat tests are handled in case of failure of a test according to a secondary test request.
In the scheme of FIG. 5, shown with reagent packs A and B (500,502), referred to as semi-linked, the pipetting order for the test is defined as proceeding from pack A to pack B (504). When either one or both of the two tests fail, only the test that failed needs to be repeated, either a repeat of the test using reagent pack A (506) or reagent pack B (508). In the scheme of FIG. 5, shown with reagent packs C and D (510, 512), referred to as strict linked, the pipetting order is defined as proceeding from pack C to pack D (514). When either one or both of the two tests fail, both the test using reagent pack C (510) and the test using reagent pack D (512) are repeated according to the same order (514). An advantage of strict linking is that it ensures that when the testing order using multiple reagents is important, it can be easily implemented in a second set of instructions.

Example 3: Representative Analytical Tests of the Second Type

In this example, representative analytical tests that can be carried out under the control of the disclosed test order manager module are described. As used in this example and in the accompanying FIGS. 6, 7 and 8, "ACN" refers to a set of instructions, which if present in the test manager module represent a second set of instructions and if present in the analyzer represent either a first set of instructions of the first type ("direct use") or a first set of instructions of the second type ("restricted").
In FIG. 6 is shown the interplay between the first test order interface, the test order manager module, and the analyzer in carrying out an antigen (Ag)/antibody (Ab)dual test (e.g. for HCV, HBV, HIV, Chikungunya, EBV, or the like). In this example, the test order manager module is shown as having stored in its memory an ACN A (600) for an Ag/Ab dual test. The analyzer is shown having loaded a reagent for the Ag test and a reagent for the Ab test, and stored in its memory an ACN B for a restricted Ag test and an ACN C for a restricted Ab test (602). Upon receipt of a test order (610) for the Ag/Ab dual test from the first test order interface, the test order manager module determines that the test order is for an analytical test of the second type and begins processing the test order (610) according to ACN A (600), to generate secondary test requests for ACN B and ACN C (612), which are transmitted to the analyzer, which processes these ACNs in parallel using the linked reagents (604; linked kits) and sends the results back to the test order manage module (614). The results of the secondary test requests are then evaluated (such as for quality, in range, out of range, etc.), and if, for example, the results are deemed reliable, a test result for ACN A is calculated in the test order manager module (616), according to ACN A, and one or more results are provided to the first test order interface (618, 620, 622) at the end of the process. The one or more results can then be provided to a user interface for display. In some embodiments, only the result of ACN A is displayed, and in other embodiments the result for ACN B and/or ACN C is also displayed or is displayed as a drill-down when the result for ACN A is selected on the display.
In FIG. 7 is shown the interplay between the first test order interface, the test order manager module, and the analyzer in carrying out a complex serological testing scheme (e.g. the Avidity IgG Serial scheme shown) that includes several decision points made according to the second set of instructions stored in the memory of a test manager module and that also illustrates the logical linking of tests. In this example, the test order manager module is shown as having stored in its memory an ACN E (700) for an Avidity IgG Serial test. The analyzer is shown having loaded a reagent for the an IgG test, a reagent for an IgM test, a Diluent, and a Pretreatment reagent, and stored in its memory an ACN A for a restricted IgG test, an ACN B for a restricted IgG reference test, an ACN C for a restricted IgG Avidity test, an ACN F for a direct use IgG test (as an example of first set of instructions of a first type for performing an analytical test of the first type, which would be used upon forwarding of a test order for ACN F directly from the test order manager module to the analyzer), an ACN D for a restricted IgM test, and an ACN G for a direct use IgM test (702).
With further reference to FIG. 7, when an order for ACN E is received at the first test order interface (710) and forwarded to the test order manager module, the test order manager module recognizes the test order as an order for an analytical test of the second type and begins processing the order according to ACN E to generate a secondary test request for ACN A (712) that is then transmitted to the analyzer, which processes ACN A (714) and sends the result of the test back to the test order manager module, where, according to ACN E, it is determined whether the test result for ACN A was positive or negative (716). If the test was negative (no), the result is provided to the first test order interface (718) and the sequence is terminated. If the test was positive (yes), the test order manager module generates an additional secondary test request for ACN D and transmits that to the analyzer, which processes the test request according to ACN D (720). The result of ACN D is transmitted back to the test order manager module where, according to ACN E, it is determined whether the result of ACN D was positive (722). If the result was negative (no), the test order manager module sends a result for ACN A and a negative result for ACN D to the first test order interface, and the process ends. If the result was positive, the test order manager module, according to ACN E, determines if the result of ACN A was above a certain predetermined threshold (728). If yes, then the test order manager module generates a further secondary test request for an additional test according to ACN A with dilution, which is transmitted to and processed by the analyzer to provide a test result that is sent back to the test order manager module (732). The test manager module then evaluates either the original test result for ACN A or the diluted result for ACN A to determine a dilution ratio (730). In either case, the test order manager module then generates secondary test requests for the logically linked ACN B and ACN C tests (734), which are transmitted to the analyzer for processing to provide results back to the test order manager module (736). The test results are then used according to ACN E to calculate a ratio (738), and the process ends when the test order manager module transmits to the first test order interface a result for ACN A (740), a positive result for ACN D (742), and the ratio result for ACN C (744). Any of or all of the various results provided to the first test order interface by the test manager module can then be transmitted to and displayed, either in a primary display, or in a drill-down display, on a user interface.
In FIG. 8, is shown the interplay between the first test order interface, the test order manager module, and the analyzer in carrying out an automated duplicate testing scheme. In this example, the test order manager module is shown as having stored in its memory an ACN C (800) for a parallel duplicate rerun testing scheme. The analyzer is shown having loaded a single reagent pack and an ACN A for direct use and a restricted ACN B (802). When a test order for ACN C arrives at the first test order interface (810) and is transmitted to the test order manager module, the test order manger module recognizes the test order as being for an analytical test of the second type and generates a first secondary test request for ACN B (812), which is then transmitted to the analyzer for processing and generation of a first result for ACN B (814). Upon receiving the first result for ACN B from the analyzer, the test order manager module determines if the first result for ACN B is negative (no) or positive(yes) (816). If the result of the first result for ACN B is negative, the result is transmitted to the first test order interface and the process of ACN C ends (818). If the first result for ACN B is positive (yes), the test order manager module generates second and third secondary test requests for ACN B (820) and transmits them to the analyzer for processing and transmission back to the test order manager module (822, 824). The test manager module then determines whether the results for both the second and third secondary test requests for ACN B are negative (826), and if they both are negative (yes), a negative result is transmitted to the first test order interface and the process according to ACN C stops (828). If both results are not negative (no), a positive result is is transmitted to the first test order interface and the process according to ACN C stops (830).
Due to the flexibility provided by carrying out testing using a test order manager module, it is possible to combine aspects of the different processes illustrated in FIGS. 6, 7 and 8, and to perform other variations thereof. For example, instead of parallel retesting in duplicate as shown in FIG. 8, retesting could be ordered serially until a minimum number of like results are obtained. Or, for example, a positive result for the process of FIG. 6 could initiate parallel retesting of the entire sequence of FIG. 6 in duplicate according to the scheme of FIG. 8. In this manner, an impactful diagnosis (such as HIV positive) could be automatically repeated two or more times to help ensure that a misdiagnosis is not provided to a patient and thus spare the patient unnecessary anguish.

Example 4: Calculated QC

In addition to handling the automated ordering of secondary test requests and performing calculations to provide a test result, the test order manager module can perform quality control calculations based upon quality control measurements where the ordered test itself does not lend itself to direct QC measurement. For example, where two different linked tests are used to provide test results that are used to calculate a final result, the QC measure for the final result should not be based on a QC measurement for a single test on which the final result is based. Furthermore, when a final result is based upon a combination of measurements that are either obtained using multiple, different measuring modules (perhaps in the same or different analyzers, and perhaps of the same or different types), it is important to provide a quality control measure that reflects the performance of the measuring modules that were used to make the measurements on the biological sample.
FIG. 9 illustrates a particular embodiment showing how a calculated QC can be provided for a test like that shown in FIG. 6, where the analyzer includes two different measuring cells. In this embodiment, the analytical test (900) involves the use of linked reagent packs (904), one for the Ag test and one for the Ab test that are used, for example, one after the other in the same measuring unit (measuring unit 1) to generate test results for the Ag and Ab (906, 908, respectively). These results are transmitted to and used by the test manager module to provide a calculated test result (910). Meanwhile, in parallel, QC measurements are being made periodically or in a triggered fashion for both the Ag test and Ab test in both of the measuring units of the analyzer (902), using the same set of linked reagent packs (904) that are used to provide the calculated test result (910). QC results (930, 932, 934, and 936, respectively) are thus obtained for Ag in measuring unit 1 (920), Ab in measuring unit 1 (922), Ag in measuring unit 2 (924), and Ab in measuring unit 2 (926). The various QC results are then used to provide 4 different calculated QC measures (940, 942, 944 and 946) that correspond to each of the combinations of how two test results can be generated in two different measuring units. The appropriate calculated QC (940) can then be assigned to the calculated result (910), which in this case means the calculated result obtained with sequential measurement of Ag and Ab in measuring unit 1 is assigned the QC result calculated from a QC measurement for Ag in measuring unit 1 and a QC measurement for Ab in measuring unit 1.
An advantage to a calculated QC scheme such as the one illustrated in FIG. 9 is that it provide the possibility to create a QC result for a test result based on multiple test measurements, which can be a regulatory requirement. Furthermore, an additional advantage is that anytime a new multi-test assay is developed, the test order manager module can be configured to provide a corresponding calculated QC measure, and such calculated QC measure schemes can be installed in parallel with, and possible as part of, a second set of instructions. Thus, whenever QC results are measured on the analyzer, a calculated QC can be provided for linked tests. And, if there are multiple measuring units, QC measurement for each test will be done on each measuring cell. If, for example, a formula for a calculated QC can contain multiple QC measures, all combinations of QC measures and measuring units can be produced. In order to avoid useless calculations of QC results, it is desirable, but not necessary that all the QC measures be produced in the same run, which means pipetting for the QC measures used to generate a calculated QC measure need only be in a timely related sequence, meaning from the same QC order, and not necessarily in a predetermined order.
In a particular embodiment, all combinations of calculated QC results out of on QC run are pre-calculated and can be assigned to a calculated sample result. After a sample is measured, the correct calculated QC result is thus assigned to the sample result. In other particular embodiments, such as where one measuring unit is reserved for performing analytical tests of the second type that utilize calculated QC, only QC measures for that particular unit need to be combined to provide calculated QC measures.
Although described above primarily with respect to combinations of tests being performed on a particular analyzer according to the second set of instructions that are used to generate secondary test requests that can be used directly or to generate additional secondary test requests on a conditional basis, the system and method described herein can be applied to even more complex combinations of tests used to reach a diagnostic result. Such more complex combinations can involve multiple analyzers, perhaps of multiple different types, analyzing one or more biological samples from a single patient (or for epidemiological purposes, multiple patients), and also perhaps multiple different types of biological samples. For example, in the area of hematology, it could be advantageous to combine results from two or more of, in any combination, a cell counting analyzer (CBC/Differential), a cellular morphology analyzer (microscopic analysis), a red blood cell sedimentation rate analyzer (physical analysis), a flow cytometer for measuring CD markers (immunological analysis), a clinical chemistry analyzer configured to perform an HbA1c test (chemical analysis), a platelet function analyzer (could be an electro-physical analyzer), a blood gas analyzer (could be an electrochemical analyzer) and a nucleic acid analyzer to reach a desired diagnosis quickly and reliably. In such embodiments, the test manager module of the disclosed system can be configured according to the second set of instructions to not only exchange test orders and test results through the first test order interface with a middleware and/or host system, but also send a request through the interface to an LIS or HIS for an additional patient sample. In a particular embodiment, a health care provider could be alerted by the disclosed system to obtain the needed sample and instructed to forward the sample to the laboratory.
Furthermore, while described as a separate computer system a computer system controlling an analyzer, it is also possible for the test order manager module to be a component of a computer system controlling one or more analyzers. In such embodiments, it is still possible to maintain vendor control over the identity and content of the second sets of instructions stored in a test manager module memory.

Claims

An analytical test management system, comprising:
a. an analyzer configured to perform an analytical test on a biological sample according to a first set of instructions, the first set of instructions stored in an analyzer memory;

b. a test manager module communicatively connected to the analyzer, the test manager module configured to direct activity of the analyzer according to a second set of instructions, the second set of instructions stored in a test manager module memory;

c. a first test order interface communicatively connected to the test manager module, the first test order interface configured to receive a test order for one of an analytical test of a first type and an analytical test of a second type and to transmit the test order to the test manager module, wherein;
i. if the test order is for the analytical test of the first type, the test manager module is configured to forward the test order directly to the analyzer and the biological sample is analyzed by the analyzer according to the first set of instructions; and wherein,

ii. if the test order is for the analytical test of the second type, the test manager module is configured to handle the test order according to the second set of instructions, and generate and transmit one or more secondary test requests to the analyzer.
The system of claim 1, wherein the analyzer memory further includes a first set of instructions of a first type and a first set of instructions of a second type, wherein the first set of instructions of the first type is used by the analyzer to process the test order for the analytical test of the first type and the first set of instructions of the second type is used by the analyzer to process the test order for the analytical test of the second type according to the one or more secondary test requests.
The system of claim 2, wherein the first set of instructions of the first type can be initiated through either the first test order interface or a second test order interface, the second test order interface communicatively connected directly to the analyzer and bypassing the test manager module, and wherein the first set of instructions of the second type can only be initiated through the first test order interface.
The system of claim 2, wherein the analyzer further includes an analyzer processor configured to, upon loading of a first reagent into the analyzer, determine whether the first reagent is to be used for the analytical test of the first type according to the first set of instructions of the first type or is to be used for the analytical test of the second type according to the first set of instructions of the second type, and if the first reagent is to be used for the analytical test of the second type according to the first set of instructions of the second type, the analyzer processor is further configured to link the first reagent to a second reagent used for the analytical test of the second type.
The system of claim 4, wherein the analyzer processor is further configured to determine if either of the first reagent or the second reagent is no longer usable, and if either the first reagent or the second reagent is determined no longer usable, the other of the first reagent and the second reagent is also made unusable by the analyzer processor.
The system of claim 4, wherein the first reagent and the second reagent are utilized according to the second set of instructions in a predetermined order.
The system of claim 6, wherein if an analytical test result obtained using either one of the first reagent and the second reagent is in error, a repeat analytical test is automatically ordered by the test manager module and the first reagent and the second reagent are both again utilized according to the second set of instructions in the predetermined order to generate a repeat analytical test result.
The system of claim 2, wherein the first set of instructions of the first type and the first set of instructions of the second type are identical except that the first set of instructions of the first type are used only for performing the analytical test of the first type whereas the first set of instructions of the second type are used only for performing the analytical test of the second type as directed by the test manager module according to the second set of instructions.
The system of claim 8, wherein a quality control result obtained by the analyzer according to the first set of instructions of the first type is transmitted to and used by the test manager module as a quality control result for an analytical result of an analytical test on the biological sample according to the first set of instructions of the second type.
The system of claim 1, wherein the one or more secondary test requests generated by the test manager module and transmitted to the analyzer comprise at least two secondary test requests, wherein the at least two secondary test requests are used by the test manager module to determine an analytical result for the analytical test of the second type.
The system of claim 1, wherein the one or more secondary test requests generated by the test manager module and transmitted to the analyzer comprise at least a first secondary test request that is used by the analyzer to generate a first secondary test result that is transmitted back to the test manager module.
The system of claim 11, wherein the test manager module is configured according to the second set of instructions to determine based on the first secondary test result whether one or more additional secondary test requests are required, and if the one or more additional secondary test requests are required, to generate and transmit the one or more additional secondary test requests to the analyzer.
The system of claim 1, further comprising a graphical user interface, the graphical user interface configured to display to a user a final result, the final result determined based on one or more secondary test results received from the analyzer following execution of the one or more secondary test requests by the analyzer, wherein the one or more secondary test results used to determine the final result are hidden from the user.
A method for managing analytical tests, comprising:
a. storing a first set of instructions in a memory of an analyzer configured to perform an analytical test on a biological sample;

b. storing a second set of instructions in a memory of a test manager module;

c. receiving a test order for one of an analytical test of a first type and an analytical test of a second type in the test manager module through a first test order interface;

d. determining in the test manager module if the test order is for the analytical test of the first type or the analytical test of the second type, and;
i. if the test request is determined to be for the analytical test of the first type, forwarding the test order directly to the analyzer to analyze the biological sample according to the first set of instructions, and;

ii. if the test order is determined to be for the analytical test of the second type, generating in the test manager module, according to the second set of instructions, one or more secondary test requests, and transmitting the one or more secondary test requests to the analyzer.
The method of claim 14, wherein the method further includes storing in the memory of the analyzer a first set of instructions of a first type and a first set of instructions of a second type, and wherein the method also includes:
a. analyzing the biological sample according to the first set of instruction of the first type if the test order is for the analytical test is of the first type; and,

b. analyzing the biological sample in response to the one or more secondary test requests according to the first set of instructions of the second type if the test order is for the analytical test is of the second type.